Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) and Exocrine Pancreatic Dysfunction in Type 1 Diabetes

September 1, 2023 updated by: Sylvie Lesage, Ciusss de L'Est de l'Île de Montréal

CFTR and Exocrine Pancreatic Dysfunction in Type 1 Diabetes

This study proposes to examine the contribution of CFTR variants to exocrine pancreatic insufficiency and hypoglycemic risk. Hypoglycemia is one the most frequent complications of type 1 diabetes management. Despite recent innovations, hypoglycemic risk remains high for people living with type 1 diabetes (PWT1D). Recent studies have shown that pancreatic insufficiency could affect hypoglycemic risk. Up to now, there are limited data on the association between pancreatic insufficiency and glucose control (i.e. the frequency and severity of hypoglycemic episodes as well as HbA1c levels). The main objective of this study is to determine the impact of pancreatic insufficiency on glucose control in PWT1D, and to address the role of CFTR variants as potential contributors to pancreatic insufficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this a one year cross sectional study, we plan to enroll 100 adults living with type 1 diabetes.

Patient data will then be separated into two groups based the presence or absence of exocrine pancreatic insufficiency (EPI). EPI will be defined based on the levels of pancreatic enzymes (Amylase; lipase; and trypsinogen). As the prevalence of EPI in people living with type 1 diabetes (PWT1D) is ~50%, we expect roughly the same number of individuals into both groups (with or without EPI).

Variables :

Subject data (age, gender, duration of diabetes, age at diagnostic, etc.) will be collected.

Glucose variation will be assessed with a continuous glucose monitoring system for 1 month. Briefly we will collect the number and severity of hyperglycemic events, average glucose levels, glycemic variability, etc..

From collected peripheral blood mononuclear cells (PBMCs) we will quantify CFTR function and level of expression, as well as identify CFTR variants by next generation sequencing.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2
        • Institut de recherches cliniques de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People living with type 1 diabetes

Description

Inclusion Criteria:

  • Type 1 diabetes
  • Living in Montreal

Exclusion Criteria:

  • Pregnancy,
  • Use of corticosteroid
  • Use of medication known to have a relevant impact on glycemic control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People living with type 1 diabetes
Participants will be separated into two groups based on the levels of their exocrine pancreatic enzymes levels.
Other: Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency
Blood samplings; Glucose monitoring; CFTR variants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and severity of hypoglycemic events
Time Frame: 1 month
Continuous glucose monitoring will be used to assess glucose regulation
1 month
Exocrine pancreatic insufficiency
Time Frame: Baseline
Blood levels of pancreatic enzymes will be measured
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborators

Juvenile Diabetes Research Foundation
Institut de Recherches Cliniques de Montreal

Investigators

  • Principal Investigator: Sylvie Lesage, Ph.D, Ciusss de L'Est de l'Île de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2022

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-INO-2022-1126-A-N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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